AB0754 REAL WORLD EVIDENCE ON DISEASE ACTIVITY IN PATIENTS WITH ANKYLOSING SPONDYLITIS TREATED WITH TUMOUR NECROSIS FACTOR INHIBITORS AND/OR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS IN ROUTINE CARE: RESULTS FROM THE “INVISIBLE” STUDY
Authors: J. Brandt-Juergens, J. Haschka, R. Finsterwalder, A. Casier, A. Kill, S. Dierckx
Journal: Annals of the Rheumatic Diseases (2022)

Background Ankylosing Spondylitis (AS) is an inflammatory rheumatic disease affecting the axial skeleton (1), with a prevalence of up to 0.5% in Europe (2; 3), and occurs in men twice as often than in women (4). 80% develop AS symptoms before the age of 30 (4). Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and biological Disease-Modifying Antirheumatic Drugs (DMARDs) such as Tumour Necrosis Factor inhibitors (TNFi) are the first choice in pharmacological treatments for AS patients (5; 6). Data on disease activity and disease control in AS patients treated in real life settings are limited. Objectives To evaluate the average disease activity status in the study population and assess the percentage of AS patients with a suboptimal treatment response following at least 12 weeks of treatment with TNFi and/or NSAIDs. Methods INVISIBLE was a real-world evidence study in Germany, Austria and Belgium. Adult patients with confirmed diagnosis of AS for at least 6 months and ongoing treatment with TNFi and/or NSAIDs for at least 12 weeks prior to enrolment were included. Primary data were collected at a single visit and medical history data from available patient files. Results 747 adult AS patients were included. 67% of patients were male, mean symptom duration 18.2 years. 77% of 696 patients were HLA-B27 positive. Appr. 23% of patients received NSAIDs, 42% received TNFi, 30% received both NSAIDs and TNFi, 5% received other treatment for at least 12 weeks prior to enrolment. Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) scores were 3.4 and 2.2, respectively. Appr. 40% of patients achieved a BASDAI score ≥4 and appr. 50% an ASDAS ≥2.1. Patients with a BASDAI score ≥4 achieved higher scores in most physician and patient reported outcomes. Overall appr. 35% of patients were not satisfied with their current symptom state according to Patient Acceptable Symptom State (PASS). Of patients with a BASDAI score ≥4 appr. 61% were not satisfied according to PASS. Conclusion Results from the non-interventional study INVISIBLE showed that a high proportion of AS patients receiving NSAIDs and/or TNFi have high disease activity according to BASDAI and ASDAS in real life settings. These results suggest that in some patients, disease control and treatment response are suboptimal under current treatment strategy. Table 1. Demographics and Disease Characteristics Total (N=747) BASDAI &lt;4 (N=445) BASDAI ≥4 (N=292) N Result N Result N Result Age in years, mean (±SD) 746 47.9 (±13.1) 445 46.7 (±13.4) 292 49.6 (±12.3)* Male, n (%) 746 500 (67.0) 445 318 (71.5) 292 176 (60.3) Age at AS diagnosis in years, mean (±SD) 745 35.2 (±12.3) 445 34.1 (±12.0) 292 36.8 (±12.5)* Treatment with NSAIDs, n (%) 744 171 (23.0) 445 85 (19.1) 290 85 (29.3) Treatment with TNFi, n (%) 744 311 (41.8) 445 208 (46.7) 290 100 (34.5) Treatment with NSAIDs and TNFi, n (%) 744 222 (29.8) 445 126 (28.3) 290 92 (31.7) Treatment with other, n (%) 744 40 (5.4) 445 26 (5.8) 290 13 (4.5) Patient disease activity assessment (VAS 0-100), mean (±SD) 735 35.8 (±27.5) 444 20.7 (±19.7) 286 59.1 (±20.7)*** BASDAI Score, mean (±SD) 737 3.4 (±2.3) 445 1.8 (±1.1) 292 5.8 (±1.3)*** ASDAS Score, mean (±SD) 599 2.2 (±1.0) 363 1.7 (±0.6) 236 3.1 (±0.7)*** ASDAS ≥2.1, n (%) 599 297 (49.6) 363 73 (20.1) 236 224 (94.9)*** PASS: current state not satisfactory, n (%) 679 240 (35.3) 403 72 (17.9) 271 166 (61.3)*** SD – Standard Deviation; Level of significance: *&lt; 0.05; ** &lt; 0.01 *** &lt; 0.001 (analyses refer to differences between BASDAI &lt;4 and ≥4 and to respective available patient number). References [ [1] Braun, J and J, Sieper. Lancet. 2007, Vol. 369, pp. 1379–90. [2] Braun, J, et al. Arthritis Rheum. 1998, Vol. 41, 1, pp. 58-67. [3] Dean, LE, et al. Rheumatology. 2014, Vol. 53, pp. 650-657. [4] Feldtkeller, E, et al. Rheumatol Int. 2003, Vol. 23, pp. 61–66. [5] Dougados, M, et al. Ann Rheum Dis. 2002, Vol. 61, suppl 3, pp. 40–50. [6] Braun, J, et al. Ann Rheum Dis. 2006, Vol. 65, pp. 316–20. Disclosure of Interests Jan Brandt-Juergens Consultant of: Abbvie, Affibody, BMS, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Judith Haschka Speakers bureau: Eli Lilly, Amgen, Consultant of: Eli Lilly, Richard Finsterwalder Employee of: Novartis Pharma GmbH, Aurélie Casier Employee of: N.V. Novartis Pharma S.A., Angela Kill Employee of: Novartis Pharma GmbH, Stéphanie Dierckx: None declared